Wednesday, July 19, 2023
Advent Therapeutics, a biotechnology company focused on developing a groundbreaking inhaled neonatal lung therapy using optimized retinol palmitate (vitamin A), has been awarded a significant $3 million grant by the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) Phase IIB program. The grant aims to support Advent's efforts in advancing its novel aerosolized vitamin A formulation for potential commercialization in 2025, with the primary goal of preventing Bronchopulmonary Dysplasia (BPD). BPD is a serious condition frequently affecting premature infants, leading to substantial morbidity and mortality, and currently lacks approved treatments.
The recent $3 million grant from the NIH adds to Advent's total NIH funding for its neonatal programs, which now surpasses $6 million. The CEO of Advent Therapeutics, David L. Lopez, expressed enthusiasm for the award, emphasizing the company's dedication to addressing the critical medical need of BPD in premature infants and reducing associated health challenges. The company aims to expedite the development process, with a focus on entering the US market first and eventually expanding globally. Advent's vitamin A drug product for injection is projected to be launched in early 2025, with estimated annual revenues exceeding $100 million for BPD prevention. Additionally, the company intends to explore other potential applications for its innovative retinol palmitate drug product, presenting significant market opportunities.
The SBIR Phase IIB grant, supported by the National Heart, Lung, and Blood Institute (NHLBI) and the National Center for Advancing Translational Sciences (NCATS), will facilitate the development of Advent's proprietary aerosolized vitamin A formulation. The funding will be utilized to complete preclinical requirements, scale up manufacturing, and conduct pivotal human clinical trials, aiming to secure marketing approvals in the US and other global markets.
Dr. Virender Rehan, Principal Investigator at the Lundquist Institute, collaborates with Advent and emphasized the importance of finding a solution for BPD, as it affects thousands of premature infants each year, leading to prolonged hospital stays, recurring hospitalizations, and significant emotional and financial burdens for families and the healthcare system.
Advent previously achieved Orphan Drug Designation in the US and Europe for its vitamin A formulation, recognizing its potential therapeutic value. The designation provides essential incentives for drug development and exclusive marketing rights following approval.
Bronchopulmonary Dysplasia (BPD) is a costly respiratory disorder affecting premature infants worldwide, with approximately 100,000 at-risk infants annually in the US and Europe alone. The total healthcare costs of treating BPD in the US have been estimated at $2.4 billion per year.
Advent is currently finalizing the manufacturing scale-up of its proprietary retinol palmitate drug product at Pace® Analytical Life Sciences, with commercial product availability expected by the fourth quarter of 2024. The company has also established a strategic partnership with dsm-firmenich, a prominent multinational company in the life sciences industry, to secure a supply of high-quality active pharmaceutical ingredient (API) and access to their Drug Master File for regulatory approvals.
Overall, Advent Therapeutics' progress and support from the NIH grant are promising signs in the quest to address BPD in premature infants and improve healthcare outcomes for this vulnerable patient population.